Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Glioma Clinical Trial

Official title:

Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122822
• Other study ID #: CS-TT-G-01
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2014
• Last updated: November 15, 2017
• Start date: July 2013
• Est. completion date: May 2017

Study information

• Verified date: November 2017
• Source: Cure&Sure Biotech Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of glioblastoma and to see how well it works in treating patients with newly diagnosed supratentoria glioma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Able to read and understand the informed consent document; must sign the informed consent.

2. Aged 18 to 75 years old , sex is not limited

3. Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection

4. Availability of at least 1 g tumor sample.

5. Karnofsky functional status rating > or equal to 70.

6. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and adequate renal function (BUN and creatinine <1.5 times IULNs)

7. Agree to Surgical indications of Heart & lung and without the coagulation system disease

8. Negative pregnancy test for female patients of childbearing potential

9. Agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration

Exclusion Criteria:

1. Inability to comply with study-related procedures

2. patient not suitable for Neurosurgery.

3. Unavailability of at least 6 doses of vaccine

4. Progression prior to vaccination as determined by the Principal Investigator

5. Patient with allergic constitution

6. Unstable or severe intercurrent medical conditions

7. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.

8. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.

9. any other clinical trials within 30 days pre-vaccination.

10. Female patients who are pregnant or breastfeeding

Related Conditions & MeSH terms

• Glioblastoma
• Glioma

Intervention

Biological:
• gp96
vaccination of autologous gp96 derived from tumor tissue + basal treatment

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Cure&Sure Biotech Co., LTD	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood count	blood count within 3 days before first vaccination	baseline
Primary	blood count	blood count within 3 days after the second injection	within 3 days after the second injection
Primary	blood count	blood count within 3 days after the 6th injection	within 3 days after the 6th injection
Primary	blood chemistries	blood chemistries test within 3 days before first vaccination	baseline
Primary	blood chemistries	blood chemistries test within 3 days after the second injection	within 3 days after the second injection
Primary	blood chemistries	blood chemistries test within 3 days after the 6th injection	within 3 days after the 6th injection
Primary	electrocardiogram	electrocardiogram test within 3 days before first vaccination	baseline
Primary	electrocardiogram	electrocardiogram test within 3 days after the second injection	within 3 days after the second injection
Primary	electrocardiogram	electrocardiogram test within 3 days after the 6th injection	within 3 days after the 6th injection
Primary	progression-free survival rate of six month	progression-free survival rate of six month	six month after surgery
Secondary	tumor control rate	tumor control rate at 6th month after surgery	six month after surgery
Secondary	progress free survive		up to 3 years
Secondary	overall survive		up to 3 years
Secondary	quality of life		up to 3 years
Secondary	changes in antigen specific T cells	tumor antigen specific T cells was determined by IFN-? Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.	baseline and within 3 days before the 6th injection